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ICD RegistryBackground Current Next Steps
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CP1262561-1
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Highlights to Date

• 1,438 hospitals
• gt135,000 implants
• 55 are primary prevention CMS patients
• 90 of implants from hospitals entering all
  patients (1 and 2 prevention, all ages)
• Longitudinal registry developed
• Research and publications in progress

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Developing the Baseline Registry

• 9/28/04 CMS published proposed NCD
• Following SCD-HeFT release
• National data base proposed
• HRS asked to chair the Working Group to develop
  the registry
• 11/22/04 Working Group recommendations sent to
  CMS
• Purpose of the registry
• Patients to be enrolled
• Patient and device data elements to be collected
• Defining providers as competent and qualified to
  implant ICDs

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Developing the Baseline Registry

• 1/27/05 CMS published final NCD
• Expanded ICD indications
• CED process described
• Data collection using QNet
• Temporary data collection tool

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What does CMS hope to gain from the Registry?

• CMSs goal is to determine whether primary
  prevention ICDs are appropriate for the Medicare
  beneficiaries who meet the clinical conditions
  identified in the agencies NCD of 1/27/05.
• Coverage with evidence development(CED)

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Coverage with evidence development

• Develop evidence on what works best in clinical
  practice . . . explicit, rapid, evidence based on
  a process that is predictable with transparency .
  . . improve the knowledge base by which patients
  and providers can make better treatment
  decisions. Mark McClellan Administrator,
  CMS 2/14/05 Conference call

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Developing the Baseline Registry

• 1/27/05 CMS published final NCD
• Expanded indications
• CED process described
• Data collection using QNet
• Temporary data collection tool
• 3/05 HRS asked to reconvene the Working Group
• Define questions that should be answered
• Define the core characteristics of a national
  clinical registry
• 5/19/05 Recommendations sent to CMS

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Developing the Baseline Registry

• 10/27/05 CMS selected the ICD Registry
  developed by ACC and HRS based on the NCDR
• 4/1/06 All data submitted to ICD Registry QNet
  phased out
• Hospitals encouraged to submit data on all
  patients
• SCD-HeFT patients -- 60 yrs
• Medicare patients -- 70 yrs
• 4/07 Quarterly benchmarking reports sent to
  hospitals
• DQR process
• Random auditing

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Developing the Longitudinal Registry
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It is particularly important that these factors
(ICD firing data and survival) be determined in
the actual population receiving ICDs, who are
older and present more comorbidities than
represented in the trial populations.
Fortunately, these key factors will be tracked in
the ICD Registry
Lynne Warner Stevenson, MD Circulation.
2006114101
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Developing the Longitudinal Registry

• 3/8/06 HRS asked to reconvene the Working
  Group
• Working Group expanded
• Refine the CED questions(group B questions)
• Develop the Longitudinal Registry

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National ICD Registry Working Group

• HRS, Chair
• HFSA
• Medtronic
• Guidant
• BCBS
• United HealthCare
• Am Hlth Ins Plans
• FDA
• CMS

• ACC
• AHA
• Biotronik
• St. Jude
• NCDR
• Aetna
• AHRQ
• Am. Hosp. Assoc.
• At large members

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Longitudinal RegistryTask Force 1 Refine the
Group B Questions

• Members
• Lynne Warner Stevenson, Chair
• Stephen Hammill (HRS)
• Gillian Sanders (Duke)
• Eric Fain (St. Jude)
• Neil Jenson (Health Partners)
• Marcel Salive (CMS)
• Joel Harder (HRS)

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Longitudinal RegistryTask Force 1 Refine the
Group B Questions

• NCD
• B1 Do patient outcomes differ for patients with
  ejection fractions above and below 30?
• Final
• B1 What are the rates of device therapies
  during the first 3 years after implantation for
  patients with LVEF 31-35 and patients with LVEF
  ?30?
• These rates will be interpreted in context of
  the absolute survival rates during the same
  period.

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Longitudinal RegistryTask Force 1 Refine the
Group B Questions

• NCD
• B2 Do patient outcomes differ for patients with
  nonischemic CHF based on time from diagnosis?
• Final
• B2 What are the rates of device therapies
  during the first 3 years for patients with a
  diagnosis of nonischemic cardiomyopathy for lt9
  months and patients with diagnosis ?9 months?

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Longitudinal RegistryTask Force 1 Refine the
Group B Questions

• NCD
• B3 Do patient outcomes differ for patients with
  Class IV CHF?
• Final
• B3 What are the rates of device therapies
  during the first 3 years for patients who are
  NYHA Class IV at the time of implantation of a
  CRT-D device and for patients who are Class III
  at the time of CRT-D placement?

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Longitudinal RegistryTask Force 2 Develop the
Methodologyto Obtain Device Therapy Data

• Members
• Peter Bach, Chair
• Stephen Hammill (HRS)
• Alan Kadish (Northwestern)
• Steve Pearson (AHIP)
• Mark Grant (BCBS)
• Bob Thompson (Medtronic)
• Marcel Salive (CMS)
• Kristi Mitchell (NCDR)
• Jeptha Curtis (Yale)
• Harlan Krumholz (Yale)
• Joel Harder (HRS)

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Longitudinal RegistryStudy Design

• Yale CORE Data analytic center
• NCDR Data collection and coordination center
• HRS Physician recruitment and oversight
• Eligible patients
• CMS beneficiaries receiving a primary prevention
  ICD

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Longitudinal RegistryStudy Design

• Primary endpoint
• First delivery of an appropriate ICD therapy
  (shock, ATP)
• Secondary endpoint
• Survival probability at 3 and 5 years
• Death from CV cause
• Total and rate of device therapies
• Ratio of inappropriate to total device therapies

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Longitudinal RegistryStudy Design

• 350 randomly selected implanting MDs
• 3,500 patients followed 3 years for events and 5
  years for survival
• Based on 10 rate of appropriate therapy at 3
  years (15 at 3 years in SCD-HeFT)
• Device therapy follow-up
• Every 3 months for a minimum of 3 years
• Adjudication process
• Data combined with NDI and Medicare claims data

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Longitudinal RegistryStudy Design

• Funding 3.5 million needed
• To date
• 1.5 million from industry
• 1.0 million from AHIP

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Longitudinal RegistryStudy Design

• Interpretation of findings
• No threshold of device therapies or survival that
  would be pre-specified to be clinically
  meaningful
• Results compared to the Baseline ICD Registry
  population to determine the appropriateness of
  ICD therapy in the 3 CED groups

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Longitudinal RegistryPatient Flow
Follow-up form
AdjudicationCommittee
Follow-up visitq3 months for3 years
ICD implantationby participatingMD
Analytic CenterData Repository
5-year clinicalfollow-up CMS billing NDI
Baseline ICDRegistry
Notification ofCoordinatingCenter
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Next Steps

• Develop version 2.0
• Research and publications
• Hospital responsible for Registry payment
• QI and P4P programs
• CMS physician performance measures (PQRI)
• Preferred Provider Status for United Health Care

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Version 2.0 Updating the Registry

• Redefine the registry purpose, goals and target
  audience
• Enhance the data collection forms and data
  collected
• Meet public policy
• Make the registry a performance reporting tool
• Post market surveillance (Sentinal Network)
• Coordinate with longitudinal data

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Research and Publications

• Research requests are reviewed and prioritized
  by Research and Publication Subcommittee
• 19 requests to date
• ICD-Registry provides financial support for data
  analysis
• Yale CORE assists with data analysis

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Research and Publications

• Sample research proposals
• How do the baseline characteristics of patients
  receiving ICD therapy in the general population
  (real world) compare with the characteristics
  of patients enrolled in randomized clinical
  trials of ICD therapy?
• Are patient outcomes such as morbidity and
  mortality affected by patient baseline clinical
  characteristics such as ejection fraction, QRS
  duration, NYHA class, gender, age, and race?

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Research and Publications

• Sample research proposals
• What are the characteristics of the physicians
  implanting ICDs regarding training, experience,
  and volume and how does this relate to
  implantation outcomes?
• Does age, race, and sex distribution of patients
  undergoing ICD implantation differ among
  different regions of the country and different
  size of hospitals?

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Why a Registry?

• Science tells us what we can doGuidelines what
  we should do and Registries what we are
  actually doing.
• Lukas Kappenberger MD
• HRS ICD Policy Conference
• Washington DC, 9/16/05

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For Additional Information
NCDR NCDR
Website www.ncdr.com
Service Center [phone] Monday Friday, 800 am 500 pm ET
E-mail ncdr_at_acc.org
Fax [phone]
Mailing address 2400 N Street NW Washington, DC 20037